Home Applications 020626 Application 020626
Type NDA
Sponsor GLAXOSMITHKLINE Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 IMITREX SUMATRIPTAN SPRAY;NASAL 5MG/SPRAY Yes Yes 002 IMITREX SUMATRIPTAN SPRAY;NASAL 10MG/SPRAY No No 003 IMITREX SUMATRIPTAN SPRAY;NASAL 20MG/SPRAY Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N020626-001 IMITREX SUMATRIPTAN 5MG/SPRAY SPRAY / NASAL AB RLD, RS 1997-08-26 N020626-002 IMITREX SUMATRIPTAN 10MG/SPRAY SPRAY / NASAL 1997-08-26 N020626-003 IMITREX SUMATRIPTAN 20MG/SPRAY SPRAY / NASAL AB RLD, RS 1997-08-26
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 1 of 4 · 126 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 N020626-001 IMITREX 5MG/SPRAY SPRAY / NASAL AB RLD, RS 1997-08-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N020626-002 IMITREX 10MG/SPRAY SPRAY / NASAL 1997-08-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N020626-003 IMITREX 20MG/SPRAY SPRAY / NASAL AB RLD, RS 1997-08-26 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N020626-001 IMITREX 5MG/SPRAY SPRAY / NASAL AB RLD, RS 1997-08-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020626-002 IMITREX 10MG/SPRAY SPRAY / NASAL 1997-08-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020626-003 IMITREX 20MG/SPRAY SPRAY / NASAL AB RLD, RS 1997-08-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020626-001 IMITREX 5MG/SPRAY SPRAY / NASAL AB RLD, RS 1997-08-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020626-002 IMITREX 10MG/SPRAY SPRAY / NASAL 1997-08-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020626-003 IMITREX 20MG/SPRAY SPRAY / NASAL AB RLD, RS 1997-08-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020626-001 IMITREX 5MG/SPRAY SPRAY / NASAL AB RLD, RS 1997-08-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020626-002 IMITREX 10MG/SPRAY SPRAY / NASAL 1997-08-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020626-003 IMITREX 20MG/SPRAY SPRAY / NASAL AB RLD, RS 1997-08-26 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020626-001 IMITREX 5MG/SPRAY SPRAY / NASAL AB RLD, RS 1997-08-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020626-002 IMITREX 10MG/SPRAY SPRAY / NASAL 1997-08-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020626-003 IMITREX 20MG/SPRAY SPRAY / NASAL AB RLD, RS 1997-08-26 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020626-001 IMITREX 5MG/SPRAY SPRAY / NASAL AB RLD, RS 1997-08-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020626-002 IMITREX 10MG/SPRAY SPRAY / NASAL 1997-08-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020626-003 IMITREX 20MG/SPRAY SPRAY / NASAL AB RLD, RS 1997-08-26 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020626-001 IMITREX 5MG/SPRAY SPRAY / NASAL AB RLD, RS 1997-08-26 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020626-002 IMITREX 10MG/SPRAY SPRAY / NASAL 1997-08-26 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020626-003 IMITREX 20MG/SPRAY SPRAY / NASAL AB RLD, RS 1997-08-26 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020626-001 IMITREX 5MG/SPRAY SPRAY / NASAL AB RLD, RS 1997-08-26 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020626-002 IMITREX 10MG/SPRAY SPRAY / NASAL 1997-08-26 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020626-003 IMITREX 20MG/SPRAY SPRAY / NASAL AB RLD, RS 1997-08-26 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020626-001 IMITREX 5MG/SPRAY SPRAY / NASAL AB RLD, RS 1997-08-26 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020626-002 IMITREX 10MG/SPRAY SPRAY / NASAL 1997-08-26 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020626-003 IMITREX 20MG/SPRAY SPRAY / NASAL AB RLD, RS 1997-08-26 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020626-001 IMITREX 5MG/SPRAY SPRAY / NASAL AB RLD, RS 1997-08-26 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020626-002 IMITREX 10MG/SPRAY SPRAY / NASAL 1997-08-26 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020626-003 IMITREX 20MG/SPRAY SPRAY / NASAL AB RLD, RS 1997-08-26 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N020626-001 IMITREX 5MG/SPRAY SPRAY / NASAL AB RLD, RS 1997-08-26 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N020626-002 IMITREX 10MG/SPRAY SPRAY / NASAL 1997-08-26 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N020626-003 IMITREX 20MG/SPRAY SPRAY / NASAL AB RLD, RS 1997-08-26 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020626-001 IMITREX 5MG/SPRAY SPRAY / NASAL AB RLD, RS 1997-08-26 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020626-002 IMITREX 10MG/SPRAY SPRAY / NASAL 1997-08-26 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020626-003 IMITREX 20MG/SPRAY SPRAY / NASAL AB RLD, RS 1997-08-26 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020626-001 IMITREX 5MG/SPRAY SPRAY / NASAL AB RLD, RS 1997-08-26 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020626-002 IMITREX 10MG/SPRAY SPRAY / NASAL 1997-08-26 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020626-003 IMITREX 20MG/SPRAY SPRAY / NASAL AB RLD, RS 1997-08-26 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020626-001 IMITREX 5MG/SPRAY SPRAY / NASAL AB RLD, RS 1997-08-26 1e350fbaab3a…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 84 observed states.
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 24 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0173-0523 IMITREX sumatriptan GlaxoSmithKline LLC NDA Current 0173-0523 IMITREX sumatriptan GlaxoSmithKline LLC NDA Current 0173-0523 IMITREX sumatriptan GlaxoSmithKline LLC NDA Current 0173-0523 IMITREX sumatriptan GlaxoSmithKline LLC NDA Current 0173-0523 IMITREX sumatriptan GlaxoSmithKline LLC NDA Current 0173-0524 IMITREX sumatriptan GlaxoSmithKline LLC NDA Current 0173-0524 IMITREX sumatriptan GlaxoSmithKline LLC NDA Current 0173-0524 IMITREX sumatriptan GlaxoSmithKline LLC NDA Current 0173-0524 IMITREX sumatriptan GlaxoSmithKline LLC NDA Current 0173-0524 IMITREX sumatriptan GlaxoSmithKline LLC NDA Current 0781-6523 SUMATRIPTAN sumatriptan Sandoz Inc NDA Current 0781-6523 SUMATRIPTAN sumatriptan Sandoz Inc NDA Current 0781-6523 SUMATRIPTAN sumatriptan Sandoz Inc NDA AUTHORIZED GENERIC Current 0781-6523 SUMATRIPTAN sumatriptan Sandoz Inc NDA AUTHORIZED GENERIC Current 0781-6524 SUMATRIPTAN sumatriptan Sandoz Inc NDA Current 0781-6524 SUMATRIPTAN sumatriptan Sandoz Inc NDA Current 0781-6524 SUMATRIPTAN sumatriptan Sandoz Inc NDA AUTHORIZED GENERIC Current 0781-6524 SUMATRIPTAN sumatriptan Sandoz Inc NDA AUTHORIZED GENERIC Current 66993-081 SUMATRIPTAN sumatriptan Prasco Laboratories NDA AUTHORIZED GENERIC Current 66993-081 SUMATRIPTAN sumatriptan Prasco Laboratories NDA AUTHORIZED GENERIC Current 66993-081 SUMATRIPTAN sumatriptan Prasco Laboratories NDA AUTHORIZED GENERIC Current 66993-082 SUMATRIPTAN sumatriptan Prasco Laboratories NDA AUTHORIZED GENERIC Current 66993-082 SUMATRIPTAN sumatriptan Prasco Laboratories NDA AUTHORIZED GENERIC Current 66993-082 SUMATRIPTAN sumatriptan Prasco Laboratories NDA AUTHORIZED GENERIC Current